Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- inspiratory flow
研究概览
简要总结
Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The dry powder inhaler device under investigation is a device approved by the Therapeutic Goods Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is currently being investigated as a treatment for bronchiectasis. We wish to measure the inspiratory flow characteristics of both the low and high resistance devices amongst a group of subjects with bronchiectasis.
We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-cf bronchiectasis
- •aged 18-80 inclusive
- •FEV1 greater or equal to 50% predicted and greater or equal to 1L
排除标准
- •uncontrolled asthma
- •CF bronchiectasis
- •have any condition for which spirometry measurement would be contraindicated
结局指标
主要结局
inspiratory flow
时间窗: single visit
次要结局
- inspiratory volume(single visit)